drugset / Trial / NCT00719875

HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer

NCT00719875

Phase 1 Completed 24 enrolled Yale University Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criteria. This study was originally intended to be a phase 1/phase 2. The protocol was amended to make this study a phase 1 only.

Timeline

Start
2008-12
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Vorinostat Small molecule 200 mg Oral

Indications